Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
INDACATEROL MALEATE (UNII: 2JEC1ITX7R) (INDACATEROL - UNII:8OR09251MQ), GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D)
Sunovion Pharmaceuticals Inc.
INDACATEROL MALEATE
INDACATEROL 27.5 ug
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
UTIBRON® NEOHALER® is a combination of indacaterol and glycopyrrolate indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Important Limitations of Use: UTIBRON NEOHALER is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1, 5.2)] . The safety and effectiveness of UTIBRON in asthma have not been established. Use of a LABA, including UTIBRON NEOHALER, without an inhaled corticosteroid is contraindicated in patients with asthma [see Warnings and Precautions (5.1)] . UTIBRON NEOHALER is not indicated for the treatment of asthma. UTIBRON NEOHALER is contraindicated in patients who have demonstrated hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients [see Warnings and Precautions (5.5)] . Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies with UTIBRON
How Supplied UTIBRON NEOHALER contains UTIBRON (indacaterol/glycopyrrolate, (27.5 mcg, 15.6 mcg) inhalation powder) in hypromellose (HPMC) capsule with yellow transparent cap and uncolored transparent body, with capsules packaged in aluminum blister cards, one NEOHALER device, and an FDA-approved Patient Information. Unit Dose (blister pack), Box of 60 (10 blister cards with 6 yellow transparent capsules each) NDC 63402-681-60 Unit Dose (blister pack), Box of 6 (1 blister card with 6 yellow transparent capsules each) NDC 63402-681-06 The NEOHALER device consists of a white protective cap and a base with mouthpiece, capsule chamber and 2 yellow push buttons. Storage and Handling Store in a dry place at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. Keep out of the reach of children.
New Drug Application
These highlights do not include all the information needed to use UTIBRON NEOHALER safely and effectively. See full prescribing information for UTIBRON NEOHALER.UTIBRON NEOHALER ®
(yoo- TEE-bron)
(indacaterol and glycopyrrolate)
inhalation powder, for oral inhalation useImportant: Do not swallow UTIBRON capsules. UTIBRON capsules are used only with the NEOHALER inhaler that comes with UTIBRON NEOHALER. Do not place a capsule in the mouthpiece of the NEOHALER inhaler.
Read the Medication Guide that comes with UTIBRON NEOHALER before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.What is the most important information I should know about UTIBRON NEOHALER?
UTIBRON NEOHALER has been approved for Chronic Obstructive Pulmonary Disease (COPD). UTIBRON NEOHALER is NOT indicated for use in asthma.
UTIBRON NEOHALER may cause serious side effects, including:
- People with asthma who take long- acting beta Pročitajte cijeli dokument
Svojstava lijeka
UTIBRON NEOHALER- INDACATEROL MALEATE AND GLYCOPYRROLATE CAPSULE SUNOVION PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE UTIBRON NEOHALER SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR UTIBRON NEOHALER. UTIBRON NEOHALER (INDACATEROL AND GLYCOPYRROLATE) INHALATION POWDER, FOR ORAL INHALATION USE INITIAL U.S. APPROVAL: 2015 RECENT MAJOR CHANGES Box Warning, Removed 05/2019 Contraindications, revised (4) 05/2019 Warnings and Precautions, revised 05/2019 Serious Asthma-Related Events – Hospitalizations, Intubations, Death (5.1) 05/2019 INDICATIONS AND USAGE UTIBRON NEOHALER is a combination of indacaterol, a long-acting beta -adrenergic agonist (LABA), and glycopyrrolate, an anticholinergic, indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). (1) Limitations of Use: Not indicated for the relief of acute bronchospasm or for the treatment of asthma. (1, 5.1, 5.2) DOSAGE AND ADMINISTRATION FOR ORAL INHALATION ONLY. DO NOT SWALLOW UTIBRON CAPSULES. ONLY USE UTIBRON CAPSULES WITH THE NEOHALER DEVICE. (2) Maintenance treatment of COPD: The inhalation of the powder contents of one UTIBRON capsule twice-daily. (2) DOSAGE FORMS AND STRENGTHS Inhalation powder: UTIBRON capsules contain 27.5 mcg of indacaterol and 15.6 mcg glycopyrrolate inhalation powder for use with the NEOHALER device. (3) CONTRAINDICATIONS Use of a LABA, including UTIBRON NEOHALER, without an inhaled corticosteroid is contraindicated in patients with asthma. (4) History of known hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients. (4, 5.5) WARNINGS AND PRECAUTIONS LABA as monotherapy (without an inhaled corticosteroid) for asthma increases the risk of serious asthma-related events (5.1) Do not initiate in acutely deteriorating COPD or to treat acute symptoms. (5.2) Do not use in combination with an additional medicine containing LABA because of Pročitajte cijeli dokumentUpozorenja za pretraživanje vezana za ovaj proizvod
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